Real-world Evidence Scientist, Neurology UCB Pharma Raleigh, North Carolina
Rationale: Brivaracetam (BRV) is indicated for monotherapy and adjunctive therapy of focal seizures in patients aged four years and older in the United States, and for adjunctive therapy in patients aged four years and older in the European Union and Australia. Real-world evidence (RWE) avoids the limited generalizability of data from patient populations typically enrolled in clinical trials. However, RWE studies of BRV so far have been restricted in scope, location, and patient numbers, limiting the identification of trends in BRV response and tolerability across key patient subgroups and precluding direct comparison of country-specific trends in BRV use. The ongoing RWE study EXPERIENCE (EPD332) will be the first with a large enough sample of patients on BRV across a wide geography (North America, Europe, Australia), clinics, and patient subgroups in routine practice to evaluate 12-month effectiveness and tolerability of BRV among patient subgroups. Identifying the patient subgroups who benefit the most from BRV may lead to better patient care. This abstract serves to highlight the potential of this large-scale study. The primary objective of the study is to assess 12-month effectiveness and tolerability of BRV. The secondary objective is to compare 12-month BRV responses in specific patient subgroups. Methods: EXPERIENCE is a retrospective, pooled study that uses clinical chart review cohorts of patients (3000+) from 30+ sites, newly treated with BRV. The analysis database will be built using a common data model to ensure consistent variable capture and allow inter-country comparisons. Eligible patients are those receiving BRV per standard practice in their region, starting at least six and, ideally, 12 months before database closure and with reliable follow-up data after starting BRV. Results: For the primary objective, overall and country/region-specific descriptive data as well as multivariate regression for BRV response by epilepsy history, baseline characteristics, and subpopulations (e.g., idiopathic generalized epilepsy, early vs late BRV add-on, elderly, post-stroke, brain tumor-related epilepsy, post-traumatic brain injury) will be presented. For the secondary objective, stratified descriptive data and multivariate regression for BRV response by patient subgroup will be presented. Outcome measures are listed in Table 1. Conclusions: EXPERIENCE is a unique opportunity to collaborate across North America, Europe, and Australia and identify clinical data from a wide range of practices, and is the first study of BRV use in routine practice across these regions. The results will be more informative about BRV effectiveness and tolerability than results from clinical trials, and will provide additional outcomes for key patient subgroups that are often excluded from clinical trials. Of note, this is the first study with the statistical power to assess patient subgroups across a wide geography, to produce the first RWE BRV findings for each key subgroup and help identify which subgroup may benefit the most from BRV. Funding: Please list any funding that was received in support of this abstract.: UCB Pharma-sponsored
